IRISpec™ CA/CB/CC is an assayed QC material for monitoring of urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only.

Device Description

IRISpec™ CA/CB/CC controls are based on a synthetic matrix simulating human urine, with preservatives and bovine-sourced biological material for serum albumin, hemoglobin, bilirubin. No human sourced materials.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the IRISpec™ CA/CB/CC device, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Device: IRISpec™ CA/CB/CC

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Ascorbic Acid Concentrate	40 mg/dL (min) - Chosen to strongly saturate ascorbic acid pads on iChem 10 SG and vChem strips.	All samples provided ascorbic acid values of 40 mg/dL.
pH	5.0 (reference) - Same as CB control.	Not explicitly stated as a test result, but presumed met as it matches the CB control and is a reference value.
Specific Gravity	1.035 (reference) - Same as CB control.	Not explicitly stated as a test result, but presumed met as it matches the CB control and is a reference value.
Base Matrix	Identical to CB buffer - Chosen so that CB could be the negative for CC for ascorbic acid.	Met; the description states the matrix for Part C is identical to Part B.
Matrix Effects	No measurement differences observed when comparing proposed CC control to human negative urine spiked with ascorbic acid at 40 mg/dL, tested in triplicate on iChem 100 Urine Chemistry Analyzer.	No measurement differences were observed.
Closed Vial Stability	No more than one grade change in concentration over a six-month period when stored at 2-8°C, compared to reference samples stored at -20°C. For negative controls (CA/CB), remaining NEG for ascorbic acid.	All vials tested had recoveries of 40 mg/dL ascorbic acid for all three lots after 7 months of real-time stability. All negative controls (CA and CB) tested NEG for ascorbic acid after 7 months of real-time stability.
Accelerated Temperature Stability (25°C)	Ascorbic acid values of 40 mg/dL during the entire study length (20 days, 16 days, 10 days, 3 days) at 25°C. Also, 40 mg/dL after 6 months at 25°C. For negative controls (CA/CB), remaining NEG for ascorbic acid after 6 months at 25°C.	All samples provided ascorbic acid values of 40 mg/dL during the entire study at 25°C. All IRISpec™ CC samples provided ascorbic acid values of 40mg/dL after 6 months at 25°C. All IRISpec™CA and CB controls were NEG for ascorbic acid.
Accelerated Temperature Stability (35°C)	Ascorbic acid values of 40 mg/dL during the entire study length (7 days, 6 days, 3 days, 1 day) at 35°C.	All samples provided ascorbic acid values of 40 mg/dL during the entire study at 35°C.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size:
- Matrix Effects: 3 lots of proposed CC control.
- Closed Vial Stability: 3 lots of proposed CC controls, plus IRISpec™CA and IRISpec™CB as negative controls.
- Accelerated Temperature Stability: 3 lots of IRISpec™CC controls, plus IRISpec™CA and IRISpec™CB for the 6-month 25°C study.
Data Provenance: The data is generated internally by the manufacturer (Iris Diagnostics, a Division of IRIS International Inc). The country of origin is implicitly the USA, where the company is located. The studies are prospective in nature, as they involve testing the performance and stability of newly manufactured lots of the device over time and under various conditions.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This device is a quality control material, not a diagnostic imaging or interpretive device that requires expert human interpretation for ground truth. The "ground truth" for this type of device is established by its formulation and verified chemical properties. The expected values (e.g., 40 mg/dL ascorbic acid) are determined by the precise manufacturing and spiking process.

Therefore, no external experts in the sense of clinicians or radiologists were used to establish ground truth for this device. The "expertise" involved would be the internal R&D and quality control personnel who formulated the control and verified its chemical composition.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth is established by the chemical formulation and direct analytical measurements, not by expert consensus or subjective interpretation requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret patient data (e.g., medical images) and the AI's impact on their performance is being evaluated. This device is a quality control material and does not involve human readers interpreting diagnostic cases.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was done

Yes, in a way, this entire submission represents a "standalone" performance study of the quality control material itself. The device (IRISpec™ CA/CB/CC) is designed to have specific chemical properties and stability. The studies evaluate whether the device itself (the "algorithm" in this context refers to the intrinsic properties of the QC material) consistently meets these specifications when tested by an analytical instrument (like the iChem 100 Urine Chemistry Analyzer). There is no "human-in-the-loop" performance being measured for the QC material directly, only its inherent performance as a standard.

7. The Type of Ground Truth Used

The ground truth used is based on chemical formulation and direct analytical measurement (laboratory analysis). The device is formulated to contain a specific concentration of ascorbic acid (40 mg/dL). Its performance is then verified by measuring this concentration using a standardized analytical instrument (iChem 100 Urine Chemistry Analyzer) and comparing it to the expected, formulated value. For negative controls, the ground truth is the absence of the analyte (NEG).

8. The Sample Size for the Training Set

Not applicable. This device is a chemical quality control material, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its "knowledge" comes from its chemical formulation and manufacturing process, not from learning from a dataset.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device.

Summary

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K072640

DEC 2 1 2007

510(k) Summary

Summary Date:

25 October, 2007

Applicant:

Iris Diagnostics, a Division of IRIS International Inc 9172 Eton Avenue Chatsworth, CA 91311 (818) 709-1244 Gerald J. Haddock, P.E. RAC, Director, Quality Assurance and Regulatory Affairs

Proprietary and Established Names:

Proprietary name: IRISpec™ CA/CB/CC

Classification name: Quality control material (assayed and unassayed).

Common name: Urinalysis controls

Device to which substantial equivalence is claimed

IRISpec Urine Chemistry Control Part A and B. Iris Diagnostics, a Division of IRIS International, Inc. Chatsworth, CA 91311

File No. K945913

Description of the proposed device:

The proposed IRISpec™ CA/CB/CC Control is identical in its parts A and B to the unmodified IRISpec Urine Chemistry Control part A and Part B control currently in commercial distribution (K945913). The only difference between the predicate device and the proposed CA/CB/CC Urinalysis Control is that the new product has a claim for ascorbic acid in part C and the predicate device does not have a claim for ascorbic acid nor a part C. The matrix for part C is identical to that of part B so that part B is the negative control for ascorbic acid.

Intended Use:

IRISpec™ CA/CB/CC is an assayed QC material for monitoring of urine chemistry analytes and devices as listed on the package insert.

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Comparison of the proposed device with the predicate device

Device	IRISpec™ CA/CB/CC(Proposed Device)	IRISpec Urine Chemistry Control, parts A and B(Predicate Device)
Similarities
Composition	CA and CB are identical to parts A and B of predicate device. Matrix for CC is identical to that of CB	Synthetic matrix simulating human urine, with preservatives and bovine-sourced biological material for serum albumin, hemoglobin, and bilirubin. No human sourced materials.
Form	Same as predicate	Liquid, ready to use
Packaging-container	Same as predicate	Glass bottle with plastic screw cap
Packaging-fill volume	Same as predicate	100 mL
Preservatives	Same as predicate	0.0048% gluteraldehyde
Storage	Same as predicate	2° to 8° CUntil expiration date
Stability-closed vial	Same as predicate	6 months at 2° to 8° C
Stability-open vial	Same as predicate	15 days at 2° to 8° C
Differences
Intended use	IRISpec™ CA/CB/CC is an assayed QC material for monitoring of urine chemistry analytes and devices as listed on the package insert.	The IRISpec Urine Chemistry Controls are intended to be used as a quality control material for all CHEMSTRIP™ urine reagent strips
Analytes	Same as predicate device except for addition of ascorbic acid in CC	Specific Gravity, pH, Protein, Glucose, Ketones, Bilirubin, Blood, Nitrite, Urobilinogen, Leukocytes

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Device Description

The following reagents are used in new CC:

L-Ascorbic Acid

Physical properties

Property	Value	Rationale for selection
Ascorbic Acidconcentration	40 mg/dL (min)	Chosen so as to strongly saturate ascorbic acidpads on iChem 10 SG and vChem strips .
pH	5.0 (ref)	Same as CB control
Specific gravity	1.035 (ref)	Same as CB control
Base matrix	Identical to CB buffer	Chosen so that CB could be the negative for CCfor ascorbic acid

Matrix Effects

Comparison testing was performed on three lots of the proposed CC control compared to human negative urine spiked with ascorbic acid at 40 mg/dL. Testing was performed in triplicate on the iChem 100 Urine Chemistry Analyzer. No measurement differences were observed.

Stability

Closed vial

Closed vial stability of proposed CC controls was verified in real time on samples from three lots stored at 2-8°C, compared to reference samples stored at -20°C. The semi-quantitative variable used as a measure of stability was concentration as measured by an iChem 100 Urine Chemistry Analyzer and iChem 10SG urine chemistry strips. The criterion for meeting the stability claim was no more than one grade change in concentration over a six month period

Samples were tested at the following time points: 1 months, 3 months, 4 months, 6 months, and 7 months. These vials were compared to vials that were stored at -20C.

All vials tested had recoveries of 40mg/dL ascorbic acid for all three lots of IRISpec™CC controls after 7 months of real time stability. This study is ongoing for internal studies only since this surpasses the 6 month shelf life claim.

All negative controls (IRISpec™CA and IRISpec™ CB) tested NEG for ascorbic acid after 7 months of real time stability. This study is ongoing. However, this also passes the 6 month shelf life claim.

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Accelerated Temperature Stability Studies

Triplicate samples of all three lots of the IRISpec™CC controls were stored at accelerated temperatures of 25° C for 20 days, 16 days, 10 days and 3 days. Triplicate samples of all three lots of IRISpec™CC controls were stored at accelerated temperatures of 35° C for 7 days, 6 days, 3 days, and 1 day. These were then compared to the triplicate samples of all three lots that were stored at 2-8° C (reference samples). All samples provided ascorbic acid values of 40 mg/dL during the entire length of the study at each temperature

Additionally, triplicate samples for all three IRISpec™ CC lots and IRISpec™ CA and IRISpec ™CB were incubated at 25°C for 6 months. These were also tested and compared to IRISpec™CC lots that were stored at 2-8° C. All IRISpec™ CC samples provided ascorbic acid values of 40mg/dL. All IRISpec™CA and CB controls were NEG for ascorbic acid, as expected.

"Surrogate" QC Material

"Surroqate" QC material effects are not applicable in the case of the part C control, because the QC material in the control is identical to the analyte it is intended to monitor.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Druq Administration 2098 Gaither Road Rockville MD 20850

DEC 2 1 2007

Iris Diagnostics, a Division of IRIS International Inc c/o Mr. Gerald J. Haddock P.E. RAC, Director, Ouality Assurance and Regulatory Affairs 9172 Eton Avenue Chatsworth, CA 91311

K072640 Re:

Trade Name: IRISpecTM CA/CB/CC Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I, reserved Product Code: JJW Dated: October 20, 2007 Received: October 22, 2007

Dear Mr. Haddock:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and 809); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indication for Use

510(k) Number (if known): K072640

Device Name: IRISpec™ CA/CB/CC

Indication For Use:

IRISpec™ CA/CB/CC is an assayed QC material for monitoring of urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use _ (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Carol C. Benam

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K072640

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.